Kornimate/medical-research-clean huggingface dataset:
improved rehabilitation after spinal surgery in adolescents

Conditions: Pain, Postoperative; Pain; Scoliosis; Spinal Fusion

Summary: impact of the ofa technique on postoperative recovery from adolescent spine surgery and the incidence of chronic postoperative pain.

racarofa is an observational, prospective study based on the hypothesis that the ofa technique effectively improves the long-term postoperative rehabilitation of adolescents and reduces the incidence of cpsp. a prospective french multicentre study on this topic is currently not feasible, as other multicentre studies (pain monitoring by the ani, blood saving strategy) would interfere with potential recruitment.

Eligibility criteria:
inclusion criteria: * patent with idiopathic or secondary surgical scoliosis * management by the paediatric anaesthesia team at the mother and child - hospital of the university hospital of nantes * non-opposition to inclusion in the study collected orally from the patient and parents * satisfying oral and written comprehension of the french language, without interpreter * ability to participate in a telephone interview exclusion criteria: * patient that does not understand french correctly * patient unable to express himself/herself correctly in french * patient with a non-scoliotic surgical spinal pathology * refusal to participate in the study * absence of a record of non-opposition to participation in the study from the patient and his or her parents * cerebral palsy or any other condition that does not allow participation in a telephone interview without particular difficulty.

Keywords: dexmedetomidine analgesics opioid free anesthesia chronic postsurgical pain
total body albumin measurement utilizing a modification of the bva 100 blood volume analyzer

Conditions: Hypoalbuminemia; Heart Failure; Nephrosis; Cirrhosis; Shock

Summary: the daxor corporation manufactures and distributes a blood volume analyzer. the analysis is based on the tracer dilution principle utilizing radioiodine labeled human serum albumin. in addition to calculating human blood volume it is hypothesized that measurement of the dilution of the tracer can also yield an accurate measurement of total body albumin.

twenty adult individuals underwent a standard blood volume measurement. the specimens for this determination are normally collected over a period of approximately 40 minutes. for the determination of total body albumin, additional specimens were collect over a three to four day period until the counts in the blood specimens were stable. calculation of the degree of dilution over this time interval is thought to represent dilution of the tracer in albumin in both the intra and extravascular space. the ratio of albumin in the intravascular to the extravascular space is available in the medical literature. the total volume in which the tracer is distributed can be determined from the dilution determined. a calculation of total body albumin is therefore possible. computation of the total body albumin for the test subjects (all normal individuals) was consistent with values for total body albumin in the literature. the purpose of the development of this method is to permit clinicians to determine albumin status in patients with disturbances in albumin such as burn patients, cirrhotic patients, nephrotic patients as well as patients with protein losing gastroenteropathies.

Eligibility criteria:
inclusion criteria: * normal adult males and females. * females in the childbearing age group to have test to exclude pregnancy exclusion criteria: * children, * pregnant females

Keywords: bva-100 blood volume analyzer human serum albumin labeled with iodine 131
study to assess safety and effectiveness of slowly increasing dose and food effect of karxt in participants with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of karxt in adult participants with schizophrenia.


Eligibility criteria:
inclusion criteria: * has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the dsm-5 (american psychiatric association 2013) criteria and confirmed by mini international neuropsychiatric interview (mini) for schizophrenia and psychotic disorder studies version 7.0.2. * positive and negative syndrome scale (panss) total score of ≤ 80 at screening and baseline. * clinical global impression-severity (cgi-s) score of ≤ 4 at screening and baseline. * willing and able to discontinue all antipsychotic medications prior to baseline visit. exclusion criteria: * history or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (gi), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. * any primary dsm-5 disorder other than schizophrenia within 12 months before screening. * history of treatment resistance to schizophrenia medications. * history of allergy/hypersensitivity to karxt. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: bms-986510 karxt dsm-5 schizophrenia diagnostic and statistical manual of mental disorders mental disorders
assessing emerald and mc10 biostamp npoint biosensors for rett syndrome

Conditions: Rett Syndrome

Summary: this is a pilot study of the emerald device in rett syndrome patients diagnosed with a confirmed mecp2 mutation. mc10 biostamp npoint patches will also be assessed with the goal to develop rett-specific breathing algorithms

the study consists of two sequential cohorts with a total of approximately 20 patients enrolled. patients in each cohort may participate for up to 4 weeks. each participant will have up to 2 emerald devices installed in their home for monitoring sleep, breathing and movement, and will use between 3 and 9 npoint patches for determining proper patch placement for detecting breathing signals. the study will consist of a screening visit, an observation period, and a follow-up phone call. the screening period will be one day in clinic, the observation period will be up to 4 weeks at home and the follow up phone call will be performed at the completion of the observation period.

Eligibility criteria:
inclusion criteria: 1. prior to the conduct of any study-specific procedures, the parent/caregiver/lar must provide written informed consent. if the caregiver attending the clinic visits is not the parent or lar, written consent must be obtained from the parent or lar for the caregiver's participation in the study. 2. diagnosis of typical rett syndrome according to the revised clinical diagnostic criteria1 and presence of a disease causing mecp2 genetic mutation. 3. the patient's parent/caregiver/lar must be able to understand the nature of the study and to allow for the completion of study assessments. the same parent/caregiver/lar must be capable of providing reliable information about the patient's condition. 4. live within approximately 50 to 60 miles of mit. 5. primary language english. 6. approximately 4 people or less living in the home. this does not include visiting caregivers. 7. must have home access to wi-fi. exclusion criteria: 1. inability of patient to sleep alone in their own room. 2. pets in the home, or caregivers unwilling to keep pets out of the bedroom monitored by emerald during the observation period. 3. plans to take a prolonged vacation or to otherwise be out of the home during the observation period. 4. participation in another device study that could interfere with this study. 5. active implantable devices such as pacemakers or defibrillators. 6. known allergies or hypersensitivities to adhesives. 7. patients with any condition that, in the opinion of the principal investigator, might interfere with the conduct of the study, confound interpretation of the study results, endanger their own well-being, or who may otherwise not be suitable for the study.
efficiency of 4-aminopyridin (fampyra) on gait, vision, cognition, fatigue and micturation in patients with multiple sclerosis

Conditions: Multiple Sclerosis; EDSS 4-7

Summary: the aim of the study is to assess improvement in visual evoked potential, cognition, fatigue, micturation and walking impairment under 3 months of fampyra treatment


Eligibility criteria:
inclusion criteria: all patients who according to the compound's norwegian prescription guidelines are deemed eligible for the study, i.e. ms patients with impaired walking as determined by an edss 4-7. they do not need a past history of optic neuritis, cognitive failure, fatigue or difficulties micturating. exclusion criteria: ms patients with contraindications to the compound according to the prescription guidelines. patients who have been exposed to fampyra in the past patients with an ms attack within last 3 months
ultrasonographic and hormonal characteristics of malawian women with and without obstetric fistula

Conditions: Obstetric Fistula

Summary: this study is a cross-sectional study of 110 malawian women to compare the ultrasonographic and hormonal characteristics of women and without obstetric fistula. hypothesis #1: women with obstetric fistula have a mean cervical length measurement that is at least 10 mm shorter than the mean cervical length measurement of similar women without obstetric fistula. hypothesis #2: evaluation of the hormonal and ultrasonographic characteristics of women with obstetric fistula will allow us to assess the cause of amenorrhea in these women.

this study is a cross-sectional study of 110 malawian women who present for medical evaluation at the fistula care centre in lilongwe, malawi. if a woman enrolls in the study, her demographic, medical history, physical exam, and lab data will be abstracted from her medical records at the fistula centre. she will also a pelvic ultrasound on each participant so that the characteristics of her cervix, uterus, and ovaries (such as the cervical length, endometrial thickness and ovarian volume) can be evaluated. if the participant has an obstetric fistula, she will also complete an additional blood draw for lab testing. the laboratory tests will evaluate three hormones that are associated with amenorrhea and infertility: follicle stimulating hormone, estradiol, and antimullerian hormone.

Eligibility criteria:
inclusion criteria: 1. presentation to the fistula care centre in lilongwe for medical evaluation 2. ability to consent for study participation in chichewa 3. female aged 18-45 years 4. willingness to undergo pelvic ultrasound for assessment of pelvic organs exclusion criteria: 1. no history of pregnancy 2. history of hysterectomy 3. current pregnancy or pregnancy within the past six weeks 4. seriously or terminally ill
intestinal microbiome and chemotherapy

Conditions: Diarrhea

Summary: chemotherapy is commonly used as myeloablative conditioning treatment to prepare patients for haematopoietic stem cell transplantation (hsct). chemotherapy leads to several side effects, with gastrointestinal (gi) mucositis being one of the most frequent. current models of gi mucositis pathophysiology are generally silent on the role of the intestinal microbiome. the aim of the study is to identify functional mechanisms by which the intestinal microbiome may play a key role in the pathophysiology of gi mucositis, the investigators applied high throughput dna-sequencing analysis to identify microbes and microbial functions that are modulated following chemotherapy.


Eligibility criteria:
inclusion criteria: * participants with non-hodgkin's lymphoma * participants receiving the same myeloablative conditioning regimen for five consecutive days, including high-dose carmustine (bis-chloroethylnitrosourea), etoposide, aracytine and melphalan. exclusion criteria: * patients with a history of inflammatory bowel diseases (ibd), exposed to probiotics, prebiotics or broad-spectrum antibiotics, or administered nasal-tube feeding or parenteral nutrition in the month prior to initiation of the study.

Keywords: post-antibiotic diarrhea intestinal microbiome
pentoxifylline for acute alcoholic hepatitis (aah)

Conditions: Hepatitis, Alcoholic

Summary: the goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in aah while studying putative mechanisms that are plausible and testable. the main hypothesis is that pentoxifylline reduces the 90-day mortality of aah.

the goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in aah while studying putative mechanisms that are plausible and testable. the main hypothesis is that pentoxifylline reduces the 90-day mortality of aah. this study never moved forward due to funding issues.

Eligibility criteria:
inclusion criteria: * inpatient with acute alcoholic hepatitis * model for end-stage liver disease (meld) of 15 or greater * recent alcohol abuse exclusion criteria: * recent infection * other life threatening disease * severe coagulopathy * another non-alcoholic cause of liver disease

Keywords: acute alcoholic hepatitis
effects of brief training on craving regulation

Conditions: Nicotine Addiction

Summary: the investigators propose that brief training in regulation of craving may increase the efficacy of smoking cessation, but that training in cognitive vs. mindfulness-based strategies may operate via different psychological and neural mechanisms.

the investigators propose to test the efficacy of such training by randomizing 126 cigarette smokers to the following conditions: 1) brief training in cognitive regulation of craving 2) mindfulness-based training, and 3) control or no training. training will be delivered in 6x1 hour computerized sessions over four weeks. control subjects simply fill out assessments during their visits. participants who were randomized into the cognitive or mindfulness training complete regulation of craving (roc) training sessions of approximately 60-90 minutes. if randomized into the cognitive regulation training, subjects will be trained to use a cognitive strategy that instructs them to think of all the negative outcomes associated with continued cigarette smoking. if randomized into the mbt-based regulation training, subjects will be trained to use a mindfulness strategy that instructs them to notice and accept their feelings of craving without judgment or intent to act upon them. after all training sessions are completed, there is a 4 week and 12 week follow-up. the investigators will evaluate the effects of training on craving and regulation of craving measured by self-report and functional magnetic resonance imaging during the regulation of craving(roc) task administered pre- and post- treatment, as well as smoking.

Eligibility criteria:
inclusion criteria: 1. between the ages of 18 and 60 2. smoking 10 or more cigarettes per day, 3. score \>4 on the fagerstrom test for nicotine dependence (ftnd) 4. treatment seeking (motivated to quit or reduce smoking; \>6 on a 10 point likert scale) 5. fluent english speaker 6. can commit to the full length of the protocol (\~8 weeks) and 7. are willing to be randomized to treatment condition. exclusion criteria: 1. current or past comorbid axis i disorders (assessed via the mini psychiatric interview diagnosis; mini) 2. current use of any psychoactive medications that have not been at a stable dose for the past 6 months, are used as mood stabilizers, or are used as smoking cessation treatments (e.g. varenicline). 3. serious or unstable medical condition within past 6 months 4. use of an investigational drug currently or within past 30 days 5. use of psychoactive medications or those that affect blood flow 6. other conditions contra-indicated for mri (e.g., claustrophobia, presence of ferromagnetic metal in the body, prior head trauma with loss of consciousness, color blindness, hypertension, pregnancy). 7. for females only: pregnancy.
safety and effectiveness of l2-7001 (interleukin-2) in hiv-positive patients receiving anti-hiv therapy

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give hiv-positive patients l2-7001 (a type of interleukin-2) plus anti-hiv therapy. interleukin-2 (il-2) is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. il-2 may be able to boost the immune systems of people with hiv infection.

this study takes place in two phases. phase a consists of an open-label dose-escalation of l2-7001 through four dose levels. ascending dose cohorts of five patients are studied. the safety and tolerability of l2-7001 is assessed in preparation for the second phase of the study and to estimate an mtd. phase b involves randomization of 190 patients to (a) one of three dose levels of l2-7001 plus art, (b) one of two dosing levels of proleukin plus art, or (c) art alone. l2-7001 and proleukin are given sc every 12 hours for the first 5 days of an 8-week cycle for three cycles. serum il-2 levels, soluble il-2 receptor levels, and levels of pro-inflammatory cytokines are evaluated in 8 patients randomized to each treatment cohort of phase b. all patients completing this phase of the protocol are eligible to be screened for enrollment in a maintenance use protocol which will allow for access to l2-7001.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive. * have a viral load below 10,000 copies/ml. * have a cd4 count between 300 and 500 cells/mm3. * have been on stable anti-hiv therapy for 4 months. patients must be taking at least 2 drugs, 1 of which must be a protease inhibitor or a nonnucleoside drug (nnrti). * are at least 18 years old. * agree to use an effective barrier method of birth control, such as condoms, during the study. exclusion criteria patients will not be eligible for this study if they: * have an aids-defining illness. (patients who have had an aids-defining illness that was cured may still be eligible.) * have an alcohol or drug abuse problem that the doctors feel would affect their ability to participate. * have cancer requiring chemotherapy. * have a history of autoimmune disease. * have uncontrolled diabetes or certain thyroid problems. * have mental illness or other serious medical condition that the doctors feel would affect their ability to participate. * have received il-2 in the past. * have taken corticosteroids or certain medications that affect the immune system in the past 4 weeks. * have taken hydroxyurea in the past 4 months. * are pregnant or breast-feeding.

Keywords: recombinant proteins injections, subcutaneous interleukin-2 dose-response relationship, drug cd4 lymphocyte count anti-hiv agents viral load pharmacokinetics
finishing hiv project

Conditions: Hiv

Summary: this study aims to learn how to help enable healthy behaviors and lower the risk of hiv among latinx men.


Eligibility criteria:
inclusion criteria 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. being 18 to 54 years of age 4. being a cis-gender male 5. self-report one or more of the following behaviors and health conditions in the last 6 months which meet the centers for disease control and prevention (cdc) clinical guidelines for prep eligibility * diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia) * sex with a partner who is living with hiv * sex without a condom with two or more partners whose hiv status were unknown * injection drug use and sharing injection equipment 6. self-reported status as hiv negative 7. willing to be tested for hiv exclusion criteria 1. display diminished capacity to consent because of: * an inability to provide informed consent (e.g., cognitive impairment) * severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to provide informed consent, as assessed by interviewers with collaborative institutional training initiative (citi) human subjects research and national institutes of health (nih) good clinical practice training 2. \ 54 years old 3. self-reported living with hiv 4. reactive hiv test (for "amigx" seeds or "yo quiero" control participants) 5. refusal of hiv test 6. identifies as non-latinx 7. individuals enrolled in other prep initiation interventions 8. individuals with an active prep prescription in the last 6-months (oral or injectable)
instant message-delivered personalised lifestyle modification intervention for pre-hypertension adults

Conditions: Pre-hypertension; Lifestyle Modification; Blood Pressure Management; Mobile Phone Use

Summary: to assess the effectiveness of instant message-delivered personalised lifestyle modification (lsm) intervention for pre-hypertension (pre-htn) management among community dwelling chinese adults.

systolic blood pressure (bp) of 120-139 or diastolic bp 80-89mmhg were previously described as 'high normal' or 'above-optimal', but have been re-defined as pre-hypertention (htn) in the seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure(jnc-7) in order to raise awareness regarding the risks of elevated bp and to emphasise healthcare professionals' roles in managing elevated blood pressures as part of primary htn prevention. prevalence of pre-htn is significant, specifically reported as 36.4% of adults in a large-scale population study conducted in mainland china. furthermore, evidence has shown that the incidence of clinical htn over 4 years in people with pre-htn is twice that of people with normal bp, of which approximately 17% had accelerated progression to more advanced stages of htn. the data highlight that a significant proportion of populations at risk of developing htn if pre-htn remains undetected and unmanaged, and also the importance of screening for pre-htn to initiate management and mitigate the risks associated with htn. lifestyle modification (lsm) is the primary intervention for people with pre-htn as they play a significant role in lowering bp without the use of pharmacological treatments. both lsm interventions and pharmacological treatments have been recommended for people with htn in clinical and public health guidelines. ecological momentary intervention (emi) is defined as a health intervention delivered though the mobile device's messaging functions, particularly instant messaging.in existing randomised controlled trials (rcts), emi also showed efficacy on lsm, including smoking cessation, diet control, psychological well-being, and weight loss. emi can therefore serve as an important 'platform' to deliver the lsm intervention in a personalised, real-time and in-situ format.

Eligibility criteria:
inclusion criteria: 1. systolic bp 120-139 or diastolic bp 80-89mmhg. the bp screening procedures and requirements (i.e., office bp measurement and abpm) will strictly follow the international society of hypertension's global hypertension practice guidelines; 2. aged ≥18 years; 3. able to read and communicate in chinese; and 4. able to use mobile phone instant messaging function. exclusion criteria: 1. ever diagnosis of htn; 2. ever diagnosis of cardiovascular diseases (cvds); 3. pregnant or \<3-month post-partum; 4. current diagnosis of psychiatric disease or currently taking a psychotropic drug; and 5. currently participating in any type of bp reduction intervention.